Protocol for a stepped wedge randomized controlled trial to optimize antibiotics prescription in Nepal

Antimicrobial resistance (AMR) is one of the top ten threats to global health. Over-prescription of antibiotics, a key driver of AMR, has been documented in many low- and middle-income countries. Low-cost interventions that do not add substantially to the physician workload, are consistent with good physician practices and WHO guidelines, and serve as a reminder on the risks of overprescribing antibiotics are critically needed. This protocol describes a study that aims to test the effect of two such interventions among junior physicians in Nepal. The first intervention requires physicians to specify the diagnosis in their prescription note-thus reminding them of the risks of over-prescription at the time of care. The second intervention provides individualized feedback on their actual prescription behavior.

The study is a stepped-wedge randomized controlled trial among an anticipated 60 physicians in 5 hospitals in Nepal, with data collected from approximately 3600 patients over a 6-month period. Physicians in the hospitals will receive the first intervention (the mandate), sequentially, beginning at the end of the first month after a refresher training on AMR. They will receive the second intervention (the feedback), again sequentially, beginning at the end of the third month. The primary outcome is the antibiotics prescription rate, which will be assessed-for both interventions-using multilevel, mixed-effect regressions (random intercepts for physicians and fixed effects for hospitals) accounting for potential confounders.

The study will contribute to current global efforts to combat AMR by utilizing low-cost, context-informed interventions to reduce inappropriate antibiotic prescribing in resource-limited settings.